a clinical trial evaluating tqb2102 for injection in combination with behmosubaisumab/payamprolizumab with or without chemotherapy in unresectable locally advanced, recurrent, or metastatic human epidermal growth factor receptor 2 (her2)-positive gastroesophageal adenocarcinoma

Conditions: Gastroesophageal Adenocarcinoma

Summary: tqb2102 for injection is a novel antibody-coupled drug (adc) that enhances binding to tumor cell surface her2 proteins by simultaneously targeting the two non-overlapping epitopes of the her2 protein, endothelial cell dysfunction 2 (ecd2) and endothelial cell dysfunction 4 (ecd4), increasing her2 internalization, and then down-regulating the tumor cell surface her2 proteins more effectively, and doubly blocking the her2 signaling, to achieve the effects of trastuzumab and pertuzumab alone and in combination. this is a phase ii study to evaluate the efficacy and safety of tqb2102 for injection in combination with benmelstobart injection /penpulimab injection ± capecitabine in patients with unresectable locally advanced, recurrent or metastatic her2-positive gastroesophageal adenocarcinoma


Eligibility criteria:
inclusion criteria: * 18 to 75 years of age, an eastern cooperative oncology group (ecog) performance status of 0 to 1, and life expectancy≥3 months; * histopathologically confirmed unresectable locally advanced, recurrent or metastatic her2-positive gastroesophageal adenocarcinoma; * her2 expression levels of immunohistochemistry(ihc) 3+ or ihc 2+ and in situ hybridization (ish) positivity were confirmed in tumor tissue; * subject is able to provide previous compliant pd-l1 expression level test results or is able to provide sufficient and competent tumor tissue for pd-l1 expression level testing; * patients who have not received prior systemic therapy for locally advanced or metastatic gastric cancer and who have experienced tumor recurrence or metastasis at least 6 months after the completion of prior adjuvant or neoadjuvant therapy may be enrolled; * confirmation of at least one measurable lesion according to recist 1.1 criteria; * the main organs function well; * male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug. exclusion criteria: * concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years; * uncontrollable toxic reactions above ctc ae grade 1 due to any prior therapy, excluding alopecia; * major surgical treatment, incisional biopsy or significant traumatic injury or prolonged unhealed wound or fracture within 28 days prior to first dose; * prior history of interstitial lung disease/pneumonia (non-infectious) requiring steroidal drug intervention or current concomitant (or suspected) interstitial lung disease/pneumonia; * arterial/venous thrombotic events, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism, have occurred within 6 months prior to the first dose; * individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders; * subjects with the presence of any severe and/or uncontrolled disease； * subjects who have received other antitumor drugs such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, or who are still within the 5 half-life of the drug (whichever occurs shortest); have received a proprietary chinese medicine with an antitumor indication as specified in the national medical products administration(nmpa) -approved drug insert within 2 weeks prior to the first dose; and have experienced any hemorrhagic or bleeding event in the month prior to the initiation of study treatment ≥ctc patients with ae grade 3; * subjects with known central nervous system (cns) metastases and/or carcinomatous meningitis * presence of severe bone damage and spinal cord compression due to tumor bone metastases; * history of live attenuated vaccination within 28 days prior to the first dose or planned live attenuated vaccination during the study; * history of severe hypersensitivity reactions to large molecule drugs or hypersensitivity to known components of tqb2102, benmelstobart or pembrolizumab for injection; * active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to the first dose of medication * diagnosis of immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy that was continued within 2 weeks prior to initiation of study treatment. * participants who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication use * unstable or serious concurrent medical conditions, as assessed by the investigators, that would substantially increase the risk-benefit ratio of participating in the study.